We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
The IMDRF has released a proposal that will guide devicemakers on producing a comprehensive Table of Contents for premarket IVD applications. Read More
EU devicemakers will have a chance to speak directly with top FDA officials at a three-day workshop on human factors for medical devices scheduled for April 1-3, 2014. Read More
Sitoa Global and the University of California San Francisco have signed a letter of intent to negotiate an option agreement for the license of a stereotactic device to deliver stem cells directly into the brain. Read More
The FDA has granted 510(k) clearance for Bruker's MALDI Biotyper CA system for the identification of Gram negative bacteria from human samples using proteomic fingerprinting. Read More
The China Food and Drug Administration has published a list of roughly 130 Class II devices that are exempt from submitting clinical trial data. Read More
San Diego-based Illumina will begin filling orders for its high-throughput gene sequencing tests and two other diagnostics by the end of the year, following FDA 510(k) clearance of all four devices. Read More
Avacen, maker of The Avacen Thermal Exchange System (TATES), was hit with a nine-citation FDA warning letter for failing to establish a host of essential GMP procedures. Read More
Devicemakers whose reported payments under the Physician Payment Sunshine Act are frequently disputed could wind up in the crosshairs for a government audit. Read More
Makers of in vitro diagnostics meant for research or investigational use only should take care not to encourage commercial use of their products. Read More
RSS
